Assessment Tool for Older Patients With Cancer

NCT ID: NCT00477958

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1062 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-19

Study Completion Date

2026-03-13

Brief Summary

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RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer.

PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.

Detailed Description

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OBJECTIVES:

Primary

* Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.

Secondary

* Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.

OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.

Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).

Patients then begin planned chemotherapy.

After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.

Conditions

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Cognitive/Functional Effects Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Geriatric Assessment Tool

Group Type EXPERIMENTAL

questionnaire administration

Intervention Type OTHER

Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.

cognitive assessment

Intervention Type PROCEDURE

Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

psychosocial assessment and care

Intervention Type PROCEDURE

Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Interventions

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questionnaire administration

Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.

Intervention Type OTHER

cognitive assessment

Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Intervention Type PROCEDURE

psychosocial assessment and care

Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Pathologically confirmed cancer

* Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen

PATIENT CHARACTERISTICS:

* Must be able to understand English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior enrollment in this trial
* No concurrent enrollment on a phase I clinical trial
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dale William, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-06170

Identifier Type: -

Identifier Source: secondary_id

MSKCC-06034

Identifier Type: -

Identifier Source: secondary_id

CDR0000540332

Identifier Type: REGISTRY

Identifier Source: secondary_id

06170

Identifier Type: -

Identifier Source: org_study_id

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